FDA 510(k) Application Details - K981759

Device Classification Name Phosphomolybdate (Colorimetric), Inorganic Phosphorus

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510(K) Number K981759
Device Name Phosphomolybdate (Colorimetric), Inorganic Phosphorus
Applicant ABBOTT LABORATORIES
DEPT. 09VA LC-2
1920 HURD DRIVE
IRVING, TX 75038 US
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Contact MARK LITTLEFIELD
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Regulation Number 862.1580

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Classification Product Code CEO
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Date Received 05/19/1998
Decision Date 06/16/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee CH - Clinical Chemistry
Review Advisory Committee CH - Clinical Chemistry
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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